Description

Summary

This phase II trial studies how well a nonavalent human papillomavirus vaccine works in preventing human papillomavirus-related cancer in adult women prior to living donor kidney transplantation. Vaccines made from peptides of human papillomavirus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

To evaluate the following in female living donor kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by: a) number of doses (1 versus [vs.] 2) of the vaccine given pre-transplant; b) time elapsed between last vaccine dose and the transplant procedure; c) variations in dosing and types of post-transplant immunosuppressant medications; and d) differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient.

II. To evaluate the following in female living donor kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: persistence and stability of HPV vaccine-type-specific geometric mean titers (GMT) at 6 and 12-months post-transplantation, and rise in HPV vaccine-type-specific GMT at the 13-months posttransplantation visit (1-month after the third/booster vaccine dose).

III. To evaluate the following in female living donor kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: vaccine safety profile and allograft rejection/opportunistic infections stratified by number of vaccine doses and time between the last vaccine dose and the transplant procedure.

IV. To evaluate the following in female living donor kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: HPV detection in samples from the cervix/vagina, and oral cavity at baseline (pre-vaccination) and at 6- and 12-months post-vaccination, overall and by number of vaccine doses (1 vs. 2), sexual behavior, type-specific seroconversion rates, and time elapsed between the last vaccine dose and the transplant procedure.

OUTLINE:

Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline and approximately 30 days after first dose. Patients then receive a booster 12 months after kidney transplant.

Keywords

Solid Organ Transplantation RecipientVaccines

Eligibility

You can join if…

Open to females ages 18–49

Female candidate for living donor renal transplant within 24 months of enrollment

Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Ability to understand and the willingness to sign a written informed consent document and medical release form

Willing and able to comply with trial protocol and follow-up

You CAN'T join if...

Previous prophylactic HPV vaccination

Prior organ transplant

Anticipated desensitization treatment

Current use of any other investigational agents

History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic composition to Gardasil 9 HPV vaccine

Pregnant or intention to get pregnant; pregnant women are excluded from this study

Carcinoma in situ (CIS) of the cervix or history of cervical cancer

History of active malignancy, including basal/squamous cell skin cancer

Prior hysterectomy

Concurrent illness, such as known psychiatric disorders or substance abuse (i.e.,average alcohol consumption of more than 3 drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the data

Patients on anticoagulation or with bleeding disorders should be evaluated by a physician for risk/benefit of bleeding disorders with intramuscular injections prior to study enrollment; patients determined to be at high risk for bleeding with intramuscular injections will be excluded